MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 324903

Device Problems Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Event Description

It was reported that the bd ultra-fine¿ insulin syringe with sterile interior had foreign matter stuck to the needle and clogged.The following information was provided by the initial reporter: the customer stated that there was a fm(clear plastic) stuck to the needle and this prevented all of the drug from the vial from entering the syringe barrel.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 05-jan-2023 h6: investigation summary customer returned (1) loose 1cc, 6mm syringe.Customer states that there was fm stuck to the needle and this prevented all of the drug from the vial from entering the syringe barrel and when injecting, the needle was not inserted deep into the skin.The returned syringe was examined visually and exhibited a hard piece of material on the cannula shaft.The sample was then examined under uv light and this material was determined to be adhesive.This could also prevent drawing into the syringe from a vial and improper injection length.A review of the device history record was completed for batch# 1347568.All inspections were performed per the applicable operations qc specifications.Embecta was able to confirm the customer¿s indicated failure.No root cause can be determined.

Event Description

It was reported that the bd ultra-fine¿ insulin syringe with sterile interior had foreign matter stuck to the needle and clogged.The following information was provided by the initial reporter: the customer stated that there was a fm(clear plastic) stuck to the needle and this prevented all of the drug from the vial from entering the syringe barrel.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15966368
• MDR Text Key: 306154916
• Report Number: 1920898-2022-00870
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324903
• Device Lot Number: 1347568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1